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Amazon receives FDA warning letter for supplements with undeclared ingredients

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Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#91

I purchased a vitamin c supplement that was pure white and odorless/tasteless. I posted a review and photos. Obviously fake filler of some sort, Amazon removed my review as inaccurate when it's obvious whatever was in those capsules was not ascorbic acid of any kind. They also claimed to have zinc (greenish) and elderberry (purple). It's not safe for Amazon to let any random exporter put stuff for sale without any sa…

When I reviewed a product as obviously fake they also removed my review. The company as a whole really kind of disgusts me now.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#92
post #6

> FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These ingredients…

Can we have an honest conversation about whether there's any good reason for Viagra to require a prescription? The barrier right now is that you have to waste 2 hours and $100 to tell a doctor that you have ED. What's the point? It's not stopping anyone except people too poor or busy to jump through the hoops.

But then you cut off the career path of an FDA lackey in becoming a big pharma exec after they've served big pharma so well. Curious if they went after supplements that don't step on big pharma products, but are actually harmful to the public they supposedly serve.

Reminds me of the X-Ray glasses and aphrodisiac ads from old magazines and comics when I was a kid.

Cosmetics get away with anti-aging and beautification claims, but I believe they are not regulated by the FDA for thise claims, because a lot if it is hogwash.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#93

I don’t think Amazon should have any protections for being a marketplace. Especially since we all found out about co-mingling, and how reviews are transferable between vendors and sometimes between products. They should be liable for any damages caused by these drugs, as well as patent/copyright/trademark infringement for any counterfeit products. I don’t feel the same for ebay, reverb, or facebook. I’m not sure wher…

Reviews are transferable? I was wondering because many reviews I have seen don't seem to be for the product I am looking at at all.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#94
post #55

Earlier quoted context omitted.

I used to think my wife was silly for spending more at beauty stores for her skincare products, but after realizing how insane Amazon's quality controls are, I think someone needs to actually shut them down. I wonder if there are any grounds for lawsuits. The number of counterfeit products they sell, even under "Sold by Amazon.com" is WILD. Zero supply chain discipline.

Can you elaborate about counterfeit products being sold under "sold by amazon.com"? That's surprising to me, I treat that as a sign of something being non-counterfeit.

I’ve ordered an Apple-brand Lightning cable from Amazon (sold by Amazon), for example, and received a counterfeit.

They replaced it, of course, but had it been a gift, or I’d been in a hurry, would anyone have noticed? If Amazon can’t keep counterfeits out of their own inventory, what chance do most buyers have?

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#95
post #89

Earlier quoted context omitted.

I'm certainly in favor of these regulations that require supplements and food products to accurately list ingredients. I'm also in favor of the FDA coming down hard on violators. But it seems perfectly reasonable that law enforcement should have to play whack a mole. That's kind and of how it works with innocent until proven guilty. I'm not a fan of the whole "you enforce it for us or we come after you" approach. In…

I think it's a distinction in risk philosophy. The whack-a-mole approach is "continue until we find you unsafe" while the other approach is "don't start until you prove you're safe". I think both approaches can be reasonable depending on the level of risk. When it comes to supplements tainted with unlisted ingredients that can have harmful or deadly effects for consumers, I personally think the latter is the better a…

But the risk level is very low. The stats I see show less than 20 hospitalizations and 2 deaths per year due to bad supplements. https://time.com/5602125/dietary-supplements-kids/

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#96
post #6

> FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These ingredients…

They are practically OTC everywhere in the world. A huge pain in the add to get in the US where the MD cartel engages in rent seeking by claiming every pharmaceutical is dangerous and they need $200 every quarter to let you buy the meds at hyper inflated prices.

Well, sure, but the solution to that is to make it OTC or added to the list of medications that pharmacists are allowed to prescribe by themselves. That way the medication dispensed is still coming from an authorized and inspected facility with adequate quality control. Mixing it with dodgy supplements is not the solution.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#97
The supplements in the letter say they contain the active ingredients found in many ED medications...

This has been going on for years with those over the counter gas station products as well.

The demand for these products is clearly big enough, and dozens of other countries sell these ED medications OTC at pharmacies.

Maybe it's time the FDA approve those drugs for sale OTC and curb the madness.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#98
post #18

More and more Amazon just seems like a "you're on your own" scam site. I can't figure out what I'm getting anymore. Half the listings are sponsored ads when I search. I searched for "Lego" this past Christmas and on the first page I got a bunch of products that were in what looked just like Lego boxes with Lego fonts and numbering ... but were not made by Lego and were clearly made to deceive. I noticed some items I…

The good thing about Amazon is that they've made it increasingly easy to stop buying from them. Finding the things you need is increasingly difficult and even if you find it, most of it seems like obvious scams. Amazon went from a bookstore to the "everything store" and back to being just a book store, because those are the only items you can reasonably find and trust to not be scams. It must be rather difficult to b…

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Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#100
post #17

Earlier quoted context omitted.

The FDA likely needs a data team if they don’t have one already to monitor Amazon for ongoing compliance. Similar to the SEC’s data team that monitors capital market data flows for anomalies that would indicate illegal behavior. My two cents: good market to be looking for good data folks who might want a (potentially remote) federal agency data job with shakiness in tech. https://usajobs.github.io/microsite-data-scie…

If you've ever been with a startup that needed a 510k, you'd know that the FDA regularly monitors everyone for compliance. At least in my narrow domain of medical imaging and treatment planning devices they do. I'd be surprised if they didn't have similar mechanisms in place in every area of their 'jurisdiction'. It doesn't really hurt the Amazons, they're just distributors. Doesn't really even hurt me. If RTP is a p…

As someone who worked at a startup that grew to a significant size in the "Nutraceuticals" industry (the fancy name for supplements), I can tell you that the FDA has nearly zero regulation or monitoring of supplements.

I'll omit brand names here, but I can tell you some sketchy stuff happens in supplement manufacturing all the time. During the ~6 years I worked there, only one letter came from the FDA after a whistleblower at a competitor's company came forward. The FDA sent a warning letter out to several of the large competitors in the industry to "don't do it or else" and never followed up again. The company that got in trouble got a few hundred thousand dollar fine for using mislabeled and toxic ingredients. They had one follow up inspection about 6 months after the warning and that was the end of it. For comparison that company was making ~$600M a year at the time of the fine and is now making $1B+. We carried on and never heard from the FDA again despite being equally guilty in our own company.

The guilt is what eventually led me away from the cash cow, where I went on an 18 month sabbatical to get away from any corporate greed for a little bit. I legitimately had nightmares that I would be complicity guilty of several crimes if I stayed there long enough.

I promise you, there is no oversight in supplements. There are a handful of posted guidelines. If a whistleblower comes forward the FDA might react to that single case, but they are so understaffed; the team that manages nutriceuticals is marked in the "tens" of people, not the thousands dedicated to proper medical equipment and medicines.

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